NCT06866899

Brief Summary

Flare reaction, characterized by excessive erythema, stiffness, and edema postoperatively, can lead to complex regional pain syndrome (CRPS) when pain is present. This study compares flare and CRPS incidence following hand surgeries performed under regional anesthesia with axillary block (RAAB) and WALANT (Wide-Awake Local Anesthesia No Tourniquet).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

3.4 years

First QC Date

March 1, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

CRPSflare reactionWALANTaxillary block

Outcome Measures

Primary Outcomes (2)

  • CRPS severity score (CSS)

    CRPS: Complex regional pain sydrome The CRPS Severity Score is a composite measure derived from multiple clinical findings, summed to provide a single score ranging from 0 to 16. The ccore is based on four major clinical domains, with each domain contributing 0 to 4 points, leading to a total possible score of 16 points. 1. Sensory Symptoms (0-4 points) Allodynia (Pain due to a stimulus that does not normally provoke pain) Hyperalgesia (Increased pain response to a normally painful stimulus) 2. Vasomotor Symptoms (0-4 points) Temperature asymmetry (≥1°C difference between affected and unaffected limb) Skin color changes (Mottled, red, cyanotic, or pale discoloration) 3. Sudomotor / Edema Symptoms (0-4 points) Abnormal sweating (Hyperhidrosis or hypohidrosis) Edema (Swelling) in the affected area 4. Motor / Trophic Symptoms (0-4 points) Motor dysfunction (Weakness, dystonia, tremors) Trophic changes (Altered nail growth, skin texture changes, or abnormal hair growth)

    Postoperative first month

  • CRPS severity score (CSS)

    CRPS: Complex regional pain sydrome The CRPS Severity Score is a composite measure derived from multiple clinical findings, summed to provide a single score ranging from 0 to 16. The ccore is based on four major clinical domains, with each domain contributing 0 to 4 points, leading to a total possible score of 16 points. 1. Sensory Symptoms (0-4 points) Allodynia (Pain due to a stimulus that does not normally provoke pain) Hyperalgesia (Increased pain response to a normally painful stimulus) 2. Vasomotor Symptoms (0-4 points) Temperature asymmetry (≥1°C difference between affected and unaffected limb) Skin color changes (Mottled, red, cyanotic, or pale discoloration) 3. Sudomotor / Edema Symptoms (0-4 points) Abnormal sweating (Hyperhidrosis or hypohidrosis) Edema (Swelling) in the affected area 4. Motor / Trophic Symptoms (0-4 points) Motor dysfunction (Weakness, dystonia, tremors) Trophic changes (Altered nail growth, skin texture changes, or abnormal hair growth)

    Postoperative third month

Secondary Outcomes (2)

  • Flare reaction

    Postoperative first month

  • Flare reaction

    Postoperative third month

Study Arms (2)

WALANT

Patients operated under WALANT (wide awake local anesthesia without tourniquet)

Procedure: Surgery for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF)Procedure: Local Anesthesia

RAAB

Patients operated under RAAB (regional anesthesia with axillary block)

Procedure: Surgery for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF)Procedure: Regional Anesthesia

Interventions

All of the patients were operated for Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF). The study is two center study, one center has the routine of RAAB (regional anesthesia with axillary block) and the other has the routine of WALANT (wide awake local anesthesia no tourniquet) for the mentioned surgeries.

RAABWALANT

Regional anesthesia with axillary block

RAAB

Wide awake local anesthesia no tourniquet

WALANT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

atients diagnosed with and operated on for Dupuytren contracture (DC), De Quervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF)

You may qualify if:

  • Patients diagnosed with and operated on for Dupuytren contracture (DC),
  • Patients diagnosed with and operated on for De Quervain tenosynovitis (DQS),
  • Patients diagnosed with and operated on for carpal tunnel syndrome (CTS),
  • Patients diagnosed with and operated on for trigger finger (TF)

You may not qualify if:

  • Patients operated under general anesthesia,
  • Patients operated with other types of regional anesthesia (eg: supraclavicular block),
  • Patients operated with other types of local anesthesia (only prilocaine or bupivacaine)
  • Patients less than 3 months follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Medical Faculty

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Surgical Procedures, OperativeAnesthesia, ConductionAnesthesia, Local

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

March 1, 2025

First Posted

March 10, 2025

Study Start

January 1, 2021

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations